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Author Topic: Handheld Computer/Programming Wand  (Read 218571 times)
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dennis100
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« Reply #1860 on: February 07, 2019, 08:19:22 PM »

Model Number MODEL 250
Event Date 12/01/2014
Event Type  Malfunction   
Event Description
It was reported that the patient's device has not been able to be checked because the physician's handheld has not been working. Further follow-up with the physician identified that an error executing run app message was observed. Troubleshooting was performed by performing a hard reset, but the message did not resolve. The flashcard was removed and reinserted and the device was powered off and then back on; however, the same message was received. Another hard reset was performed and the issue did not resolve. No additional relevant information has been received to date.
 
Event Description
The handheld, flashcard, and programming wand were received for analysis. Analysis of the programming wand was completed on 02/27/2015. The programming wand performed according to functional specifications. Analysis of the handheld and flashcard are underway, but have not been completed to date.
 
Event Description
The handheld and flashcard are expected to be returned, but have not been received to date.
 
Event Description
An analysis was performed on the returned programming handheld and flashcard. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. During the analysis of the handheld, it was identified that the handheld was unable to load the vns version 8. 1 software. The cause for the anomaly is associated with a bent pin in the flashcard slot. Once the pin was straightened, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.
 
Manufacturer Narrative

Manufacturer Narrative
New information received corrects the suspect device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4417857
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dennis100
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« Reply #1861 on: February 07, 2019, 08:21:00 PM »

Model Number MODEL 250
Event Date 12/12/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the handheld device was making a rattling noise. Performance of the device was affected. The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned handheld device and software flashcard was completed. The cause for the reported allegation is associated with a loose screw inside the handheld case. The screw was 1 of 4 screws that are used to secure the display to the main pcb. No functional anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. No anomalies associated with flashcard software were identified during the flashcard analysis.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4403303
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dennis100
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« Reply #1862 on: February 08, 2019, 12:22:18 AM »

Model Number MODEL 3000
Device Problems Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings
Event Date 11/15/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Initial report was that a patient was referred for replacement due to eos. Further information was received that the patient's generator was replaced due to high impedance. The patient's neurologist did not feel that the lead was compromised but that the high impedance was due to the upgraded tablet software and the fact that the patient had a m102 device. The neurologist stated in his notes to the surgeon that the impedance was higher than normal and that the surgeon should visually inspect and try a new generator before replacing the lead. Per the received implant card, only the patient's generator was replaced. For model 102/102r generators programmed to output currents > 1 ma , it was observed that system diagnostics using m3000 v1. 0 and m250 software would display ok lead impedance while system diagnostics using m3000 v1. 5 software would display a false high impedance. This is likely what the physician was referring to when indicating that he believed the upgraded tablet software was the cause of the high impedance. The generator has not been received to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8216840
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dennis100
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« Reply #1863 on: February 08, 2019, 12:23:00 AM »

Model Number 3000-V1.5
Device Problem Computer Software Problem
Event Date 12/26/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the physician ran diagnostics on the patient's vns and it was stated that it looked like there were lead issues. High impedance was observed on the patient's m102 vns generator when using the physician's m3000 v1. 5. 2. 1 vns programming system with a dcdc code of 4. However, diagnostics with a motion vns programming tablet revealed that the high impedance reading was false. This issue was duplicated with in-house testing. For model 102/102r generators programmed to output currents greater than 1. 00 ma , it was observed that system diagnostics using m3000 v1. 0 and m250 software would display ok lead impedance while system diagnostics using m3000 v1. 5 software would display a false high impedance. It was determined that the cause of this false high impedance message was a software error on m3000 v1. 5. 2. 1 software; when system diagnostics were performed by the user with m3000 v1. 5. 2. 1 software on m102/102r generators (normal mode output current;0 ma), normal mode diagnostics would actually be performed instead. The execution of normal diagnostics instead of system diagnostics is not apparent to the user, and the returned dcdc code was being compared against system diagnostic thresholds. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8262486
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« Reply #1864 on: February 08, 2019, 12:23:36 AM »

Model Number MODEL 3000
Device Problems Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings
Event Date 09/25/2018
Event Type  Malfunction   
Event Description
It was found during periodic history review that high impedance was detected on a patient¿s m102 generator with m3000 version 1. 5. 2. 1 programming system. It was previously determined through in-house testing that, for model 102/102r generators programmed to output currents > 1ma, system diagnostics using m3000 v1. 0 and m250 software would display ok lead impedance while system diagnostics using m3000 v1. 5. 2. 1 software would display a false high impedance. The cause of these false high impedance messages was a software error on m3000 v1. 5. 1. 2 software; when system diagnostics were performed by the user with m3000 v1. 5. 2. 1 software on m102/102r generators (normal mode output current;0 ma), normal mode diagnostics would actually be performed instead. The execution of normal diagnostics instead of system diagnostics is not apparent to the user, and the returned dcdc code was being compared against system diagnostic thresholds. As the patient's replacement was stated to be due to battery depletion and the lead was not replaced, it is assumed that the patient's replacement was not due to high impedance. The lead impedance was within normal limits when a new generator was implanted. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8262691
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dennis100
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« Reply #1865 on: February 08, 2019, 12:24:15 AM »

Model Number MODEL 3000
Device Problems Computer Software Problem; High impedance; Incorrect, Inadequate or Imprecise Result or Readings
Event Date 11/27/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Clinic notes were received which reported that this patient was referred to neurosurgery due to a recent interrogation showing high lead impedance. The notes indicate that the patient may need both a lead revision and battery generator replacement. Additional information was received that the patient underwent surgery where only the generator was replaced and it was stated to be a prophylactic replacement. The lead was not replaced at this time. High impedance was not observed after surgery, and diagnostics were within normal limits. The explant facility historically has reported that they cannot release explanted devices without the patient signing a release. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8216839
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« Reply #1866 on: February 10, 2019, 03:01:21 AM »

Model Number MODEL 250
Event Date 12/17/2014
Event Type  Malfunction   
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
The tablet was received for analysis. An analysis was performed on the returned tablet, and the reported allegation was verified. No anomalies associated with the main battery were identified during the analysis. However, analysis confirmed a defective motherboard which contributed to the complaint. Once the board was replaced, no further anomalies associated with the tablet were identified during the analysis.
 
Event Description
It was reported that the physician¿s programming tablet would not power on. The company representative tried using his tablet's power cable with the physician¿s tablet and a different wall outlet was used. However, the issue persisted. A replacement tablet was provided to the physician's office. The suspect tablet has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4396265
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dennis100
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« Reply #1867 on: February 10, 2019, 03:02:12 AM »

Model Number MODEL 250
Event Date 12/01/2014
Event Type  Malfunction   
Event Description
It was reported that the physician¿s tablet usb port was broken, and as a result, the cable would not fit into the tablet. The tablet was received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
Analysis of the tablet was completed on 01/20/2015. During the analysis, it was identified that the usb port was damaged. As a result, the tablet was unable to establish communication and generating port error messages. No further anomalies were identified.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377491
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« Reply #1868 on: February 10, 2019, 03:03:20 AM »

Model Number MODEL 250
Event Date 10/30/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the physician's programming system was unable to interrogate a known working generator. Troubleshooting was performed which identified that the physician's programming system was found to not interrogate. The physician was provided a new programming system and the handheld and wand were returned for analysis. Analysis of the handheld was completed on (b)(4) 2014. During the analysis an intermittent power connection associated with the serial cable was identified. The cause for the anomaly is associated with a bent serial cable plug leaf spring that prevented electrical contact with the ac adapter barrel connector. The cause for the bent spring is unknown, but is most likely associated with mishandling of the device. Analysis of the flashcard was completed on (b)(4) 2014. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Analysis of the wand was completed on (b)(4) 2014. The returned battery was depleted and was not the recommended type per labeling (battery type labeling recommends alkaline). After the battery was substituted, the programming wand performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4392435
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dennis100
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« Reply #1869 on: February 10, 2019, 03:04:35 AM »

Model Number MODEL 250
Event Date 12/03/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative

Event Description
It was reported that the nurse practitioner's handheld will not hold a charge. A new programming tablet was provided to the nurse practitioner. The handheld was received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the returned handheld device and software flashcard was completed. No anomalies associated with the handheld main battery were identified during the analysis. The following anomalies were identified: 1) the battery latch was unlocked, preventing the handheld from turning on; 2) the display image was distorted and the inner display glass was cracked ¿ cause associated with mechanical stress; 3) the touchscreen was unresponsive ¿ cause associated with high impedance in the touchscreen circuitry, 4) the serial cable had an intermittent open connection causing the handheld to lose power intermittently while on ac power ¿ cause associated with mechanical stress. Following replacement with a known good screen, full product functionality was restored. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4393758
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« Reply #1870 on: February 11, 2019, 01:22:56 AM »

Model Number MODEL 250
Event Date 01/14/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the handheld¿s serial cable needed to be manipulated in order to work. A new serial cable was tried and the physician still had to ¿wiggle¿ the cable to get it to work, therefore it was believed the issue is with the handheld. The old serial cable worked fine with another programming system. Attempts have been made for product return but it has not been received to date.
 
Event Description
On 03/06/2015 product analysis was completed on the serial cable. No anomalies associated with the serial cable were noted during testing. The serial cable performed according to functional specifications. Product analysis was completed on the handheld on 03/18/2015. During the analysis it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged leads associated with the handheld sync connector. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Product analysis was also completed on the flashcard. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
On (b)(46) 2015 the serial cable was returned for product analysis. On (b)(6) 2015 the handheld and flashcard were returned for product analysis. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4491144
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dennis100
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« Reply #1871 on: February 11, 2019, 01:23:40 AM »

Model Number MODEL 250
Event Date 01/15/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the serial cable was disposed by the facility and cannot be returned for analysis.
 
Event Description
It was reported that the nurse was having issues performing interrogations with her programming system. The programming system displayed an ¿unable to open port: the system cannot find the file specified¿ error message. The connections were checked, the programming wand battery was replaced, and the programming wand was reset; however, the issues did not resolve. Clinic notes were received indicating that the issues were believed to be due to the serial adaptor of the tablet device. The suspect serial cable has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4494052
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« Reply #1872 on: February 11, 2019, 01:24:19 AM »

Model Number MODEL 250
Event Date 01/15/2015
Event Type  Malfunction   
Event Description
It was reported that the tablet device would not hold a charge for more than an hour. While plugged in to the power adaptor, the charging indicator was on and the tablet worked fine. The tablet device was returned to the manufacturer for analysis which identified that the tablet could not charge the main battery, and as a result was also not able to be powered using the main battery. The cause for the identified anomaly is associated with a loose battery cable to the motherboard. Once the cable was reseated, no further anomalies were identified during the analysis.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
The design history record was reviewed and the device passed all manufacturing and quality control inspection steps prior to shipment. No anomalies observed in review of the device history record.
 
Event Description
Product analysis for the tablet was completed and approved on 04/06/2015. An analysis was performed on the returned tablet and the reported allegation was not verified. No anomalies associated with the main battery were identified during the analysis. During the analysis, it was identified that the tablet could not charge the main battery, and as a result was also not able to be powered using the main battery. The cause for the identified anomaly is associated with a loose battery cable to the motherboard. Once the cable was reseated, no further anomalies were identified during the analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4494098
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« Reply #1873 on: February 12, 2019, 02:34:57 AM »

Model Number MODEL 250
Event Date 01/27/2015
Event Type  Malfunction   
Event Description
It was reported that the programming tablet has been charging for a long time and the battery light is still flashing amber. The tablet was unplugged and immediately powered off and would not power back on. The tablet was plugged back into the power cord and the battery light illuminated red and then flashed amber again. It was reported that the tablet was last used on (b)(6) 2014 and that it had been plugged into a power source for a long time. After 10 minutes the tablet was again removed from the power source and immediately powered off and would not power back on. The site was provided a new programming tablet and the non-functional tablet was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
The loose cable was identified as a possible cause for the battery not holding its charge, but the failure could not be confirmed.
 
Event Description
Product analysis was completed for the tablet device. A visual analysis inside the tablet case identified a loose cable that connects the main battery to the motherboard. This condition can cause an intermittent electrical connection that can prevent the tablet from operating on battery power and charging the main battery. With the tablet in its ¿as received¿ condition no anomalies associated with the tablet performance were noted during testing. The tablet performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4542038
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« Reply #1874 on: February 13, 2019, 01:43:26 AM »

Model Number MODEL 250
Event Date 01/26/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 it was reported that the handheld may have gotten ¿zapped¿.
 
Manufacturer Narrative

Event Description
It was reported that the physician was having difficulty turning on the programming handheld. The screen lock button, the battery latch, and the wall outlet were all checked, which did not resolve the issue. A soft reset was performed but the handheld only flashed the red light on the power button and nothing appeared on the screen. A hard reset only resulted in a ¿¿battery critically low¿ message appearing on the screen. The office had another programming handheld and when they tried to plug that one into the power cable of the first programming handheld, there was an inability to charge that one as well. It was therefore believed that the issue may be with the power cable and a new power cable was sent to the physician, but this did not resolve the issue with the programming handheld not turning on. It was reported that the programming handheld would be returned for product analysis but it has not been received to date.
 
Event Description
The handheld and flashcard were received for analysis. Analysis of the handheld was completed on (b)(4) 2015. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged leads associated with the handheld sync connector. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Analysis of the flashcard was completed on (b)(4) 2015. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4524519
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« Reply #1875 on: February 13, 2019, 01:44:19 AM »

Model Number MODEL 250
Event Date 01/01/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative

Event Description
It was reported that the handheld device would only work while it was charging. Once the handheld was disconnected to the power adaptor, the screen went blank. The handheld device has not been returned to date.
 
Event Description
The handheld computer and the software flashcard were retuned to the manufacturer on 03/16/2015. Analysis of the handheld computer found no anomaly associated with the performance of the handheld¿s display. The handheld was returned without a battery cover. As a result, the handheld would not power ¿on¿. A known good battery cover was used to complete testing. One of the leaf springs associated with the main battery terminal on the main pcb was bent which rendered the main battery unable to establish electrical contact with the handheld, which did not permit the battery recharge using the ac power. Also the handheld was unable to be powered using the main battery. Once the leaf spring was bent back into place, the handheld performed according to specifications. Analysis of the flashcard identified no anomalies associated with flashcard software. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4519346
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« Reply #1876 on: February 14, 2019, 01:17:09 AM »

Model Number 201
Event Date 03/04/2015
Event Type  Malfunction   
Event Description
Additional information was received from the physician reporting that the communication issue was related to a depleted 9v wand battery. After 9v wand battery replacement, the programming system now functions.
 
Manufacturer Narrative

Event Description
On (b)(6) 2015 it was reported that the physician was having difficulty interrogating the patient's device, it kept giving ¿procedure failed, checksum error" messages. He reported that he had just recently interrogated several other patients without issue. No further information was received as the physician ended the call. Good faith attempts for further information from the physician were unsuccessful.
 
Manufacturer Narrative
(b)(4). The initial mdr inadvertently did not include the udi for the suspect device at the time. The suspect device for the event was updated from the generator to the programming wand in supplemental mdr #01.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4637643
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« Reply #1877 on: February 14, 2019, 01:18:04 AM »

Model Number MODEL 250
Event Date 03/05/2015
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld would not power on after being plugged into an electrical outlet for approximately 10 minutes. It was reported that the power light illuminated orange indicating that there was power to the handheld. A hard reset was performed which did not resolve the issue. The handheld was left plugged to the power outlet for a while longer and then troubleshooting was again attempted. The handheld would still not power on so the physician was provided a new programming computer. The handheld and flashcard were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Product analysis was completed for the handheld device on 04/20/2015. The cause for the failure to power on is associated with a defective main board. Once the board was replaced, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. Product analysis was completed for the software flashcard on 04/20/2015. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4641640
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« Reply #1878 on: February 15, 2019, 02:48:57 AM »

Model Number MODEL 250
Event Date 03/04/2015
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction caused event but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative

Event Description
Analysis of the tablet was completed on 04/28/2015. The tablet was returned for a reported mechanical problem, serial adapter/cord failure. An analysis was performed on the returned tablet and the reported allegation was verified. The cause for the anomaly is associated with a broken wire connection in the serial cable db9 hood assembly. Once the wire was soldered on to the pcb, no further anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.
 
Event Description
On (b)(6) 2015 the programming tablet and usb cable were received for product analysis. Product analysis is still underway and has not yet been completed.
 
Event Description
It was reported that the physician's tablet was giving a "failure to open port" message. It was mentioned that the usb serial connector on the programmer was "really loose" and they felt that was likely the issue. A new usb serial cable was requested and sent but this did not fix the issue, therefore the issue was believed to be due to the tablet. Attempts have been made for the return of the tablet but it has not been received for product analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4628497
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« Reply #1879 on: February 16, 2019, 01:29:19 AM »

Model Number 102R
Event Date 01/29/2015
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2015 reported status epilepticus was on the new problem list. The chief complaint was seizures with dead vns battery. The patient moved residences the week prior and had her first seizure in a while. The physician assessed that the patient experienced recurrent seizures since. Additionally, it was noted that some of her medications were previously discontinued by the previously treating physician. The patient¿s generator was unable to be interrogated due to suspected end of service by the physician. The physician reported in the notes that the patient is sensitive to the vns and reports having seizure when being tested. The patient developed complex partial status epilepticus in the clinic. The patient was transferred to the medical care center. No known surgical intervention has occurred to date. Good faith attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The explanted generator was received for analysis. However, analysis has not been completed to date. The reason for replacement was reported to be prophylactic n the return paperwork.
 
Event Description
Additional information reported that the patient was scheduled for generator replacement due to the device not working. Generator replacement occurred on (b)(6) 2015. It was reported that the explanted device could be interrogated pre-operatively. It was reported to not be at end of service condition and diagnostics were within normal limits (dcdc-2). The lead was not replaced. The explanted generator has not been received by the manufacturer for analysis to date.
 
Manufacturer Narrative

Event Description
Analysis of the generator was completed. The reported failure to program was duplicated (not due to end of service of the battery) in the analysis laboratory at two orientations. This is addressed in the vns physicians manual by instructing the user to reposition the wand. Since product labeling addresses these situations and provides instructions to easily remedy the events (wand position and system operation), it is not considered a device malfunction. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Additional information was received from the treating physician¿s office. It was reported that they have not had any vns programming system issues since the patient's device could not be interrogated. They elected to refer the patient for generator replacement surgery due to battery depletion and prophylactic lead replacement. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4621721
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« Reply #1880 on: February 17, 2019, 05:27:42 AM »

Model Number MODEL 250
Event Date 02/09/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
On 03/23/2015 product analysis was completed on the tablet. During the analysis it was verified that the pen release button latch was damaged. The cause for the damage is unknown, but is most likely associated with mishandling of the tablet. Other than the damage to the pen release button latch, no other anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge. The tablet performed according to functional specifications.
 
Event Description
On (b)(4) 2015 it was reported that there was an issue with the tablet¿s stylus door failing to open when the button is pushed. The tablet was returned for product analysis on (b)(4) 2015. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4570196
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dennis100
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« Reply #1881 on: February 17, 2019, 05:28:31 AM »

Model Number MODEL 250
Event Date 02/09/2015
Event Type  Malfunction   
Event Description
Product analysis was completed for the tablet device. No anomalies associated with the main battery were identified during the analysis. During the analysis, it was identified that the tablet could not charge the main battery, and as a result was also not able to be powered using the main battery. The cause for the identified anomaly is associated with a loose battery cable to the motherboard. Once the cable was reseated, no further anomalies were identified during the analysis.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative

Event Description
It was reported that the tablet device would not hold a charge. The tablet was allowed to charge for a long period of time but would turn off when unplugged from the power adaptor. The tablet device has been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4577346
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dennis100
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« Reply #1882 on: February 17, 2019, 05:29:06 AM »

Model Number MODEL 250
Event Date 02/11/2015
Event Type  Malfunction   
Event Description
Product analysis was completed for the handheld device and software flashcard. No anomalies associated with the handheld device or software flashcard were noted during testing. The handheld device and software flashcard performed according to functional specifications. Information was received that the issue was resolved with the new tablet. The handheld device serial cable will not be returning for analysis.
 
Event Description
It was reported that the handheld device showed a "check sum¿ error message. It was confirmed that there were no issues with the wand battery. The handheld was not plugged into the power outlet and a hard reset did not resolve the issue. Interrogation was attempted in a different area of the room but the issues continued. The components of the programming system were switched out but the source of the issue could not be located. The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4582152
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